Kornimate/medical-research-clean huggingface dataset:
effects of a sedentary behaviors at work on health in emergency medical dispatchers and codis operators (secodis)

Conditions: Sedentary Behavior; Occupational Stress

Summary: the purpose of the study is to study changes in sedentary behavior following a behavioral intervention (sit-and-stand desk, and cycloergometer)

each emergency medical services dispatcher and each firefighter participates in the study for three days. a normal working day from of 12h is compared to: (i) a working day during which the participants have to get up at least 5 min/hour (sit-and-stand desk), (ii) a working day during which they can use a cycloergometer installed under the desk. conditions will be random using latin square design with stratification between sequences cross-over design on occupation (emd vs. firefighters). the heart rate variability (measured using zephyr®), the electrodermal activity (empatica® e4), the level of physical activity (actigraph®) as well as the blood sugar (freestyle®) will be measured continuously during the 12 hours of work and the night after except for actigraph® and freestyle® device that will be let one week. blood and saliva samples will be collected on each working day, at the beginning and end of the day i.e. two measures for blood samples, and every three hours i.e. 5 measures for saliva sampling. participants will have to complete a detailed questionnaire to identify the particular events (vital emergencies, etc.) that may influence the parameters measured. participants will be asked to answer a general questionnaire once at the start of the study that will cover different aspects: * sociodemographic, * visual analogue scale (vas) related to psychosocial factors : stress at home, burnout / burnout, decision latitude / autonomy at work, psychological demands at work (workload), support from the hierarchy, support from co-workers, family support, job satisfaction with regard to effort, commitment to work, addiction to work, quality of life, need for psychological support, * eating habits. they will then have to answer a short questionnaire at the beginning and at the end of each measurement day. it will cover different aspects: * four vas (stress level, fatigue, anxiety, mood), * physical activity and sedentary lifestyle (number of hours of physical activity and sitting during the last 24 hours), * daily consumption (tobacco, alcohol, cannabis, coffee, tea).

Eligibility criteria:
inclusion criteria: * emergency medical dispatchers or firefighters from the departmental fire and rescue operational center (codis). * person able to give an informed consent to participate in research * affiliated with a social security scheme. * being able to use the sit-stand desk and the cycle ergometer exclusion criteria: * non-affiliated to a health insurance, * protected persons (minors, pregnant women, breastfeeding women, guardianship, curatorship, deprived of freedoms, safeguard of justice), * refusal to participate.
performance proof of product developed to detect abnormal vaginal ph

Conditions: Vaginal Infection

Summary: this study was designed to validate the color appearance on the norma-sense gen 3 when comes into contact with vaginal secretions having an elevated ph level

this study was designed to validate the color appearance on the norma-sense gen 3. the norma-sense gen 3 changes color when worn by the user and comes into contact with vaginal secretions having an elevated ph level, without false positives due to urine remains or incontinence. the study will also asses the physical comfort in using norma-sense gen 3 and the result reading clarity which includes the ability to visualize and interpret the norma-sense gen 3 results.

Eligibility criteria:
inclusion criteria: 1. women, age 18 years or greater with or without symptoms of vaginal infection. 2. subject is ready to sign the informed consent form. exclusion criteria: 1. subject is unable or unwilling to cooperate with study procedures. 2. subject is currently participating in another clinical study. 3. subject suffers from vaginal bleeding or is menstruating. 4. subject that have had sexual relations within the last 12 hours. 5. subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days. 6. subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Keywords: ph screening early warning vaginal health vaginal secretion vaginal ph
a phase ii study of adjuvant use of anti-epidermal growth factor receptor egfr-425 in high grade gliomas

Conditions: Gliomas

Summary: data from the wistar institute indicated that this anti-body labeled with iodine-125 would localized in the tumor cells of high grade gliomas of the brain. the project combines surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase ii trial in this disease entity.

this is an open-label phase ii study of postoperative radiation therapy followed by iodine-125 radiolabeled anti-epidermal-growth-factor-receptor monoclonal antibody (125i-mab 425) derived from cell cultures for high grade malignant gliomas. each subject will receive postoperative radiation therapy followed by 6.4 mg of 50 mci labeled 125i-mab 425 by injection. this dosing regimen will be given three times generally within a two-week period (days one, eight and 15 of therapy) for a total dose of 19.2 mg of 150 mci labeled 125i-mab 425 for each course of therapy. the main objective of this study is to determine if the addition of 125i-mab 425 to postoperative radiotherapy, with or without change, prolongs absolute survival compared to historical control (postoperative radiation therapy alone) in subjects with histologically proven high grade gliomas. the primary efficacy variable is absolute survival and the secondary target variable will be time to progression of the tumor. multiple courses will be considered based on the subject's clinical status.

Eligibility criteria:
inclusion criteria: * all cases above 18 years of age exclusion criteria:

Keywords: high grade gliomas of the brain anti-body treatment survival
a research study to see how semaglutide helps people with excess weight, lose weight (step up)

Conditions: Obesity

Summary: this study will look at how much weight participants will lose from the start to the end of the study. the weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. in addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. participants will either get semaglutide or "dummy" medicine. which treatment participants get is decided by chance. participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. the study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. in the first part of the study, participants will get one injection once a week until they reach the planned dose. the second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. the duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.


Eligibility criteria:
inclusion criteria: * male or female. * age above or equal to 18 years at the time of signing informed consent. * body mass index (bmi) greater than or equal to 30.0 kilogram per square meter (kg/m\^2). * history of at least one self-reported unsuccessful dietary effort to lose body weight. exclusion criteria: * hba1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening. * history of type 1 or type 2 diabetes. * treatment with glucose-lowering agent(s) within 90 days before screening. * a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening irrespective of medical records. * personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
lifestyle modifications and the progression of chronic kidney disease

Conditions: Patients With Stage 2-4 Chronic Kidney Disease

Summary: aerobic training has been shown to favorably alter several of the known risk factors for coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). it seems logical that if these risk factors were aggressively controlled in patients with chronic kidney disease (ckd) by implementing lifestyle changes (e.g., diet and exercise training) to support the pharmacologic interventions that are necessary for the control of the disease, then the rate of progression of the disease may be altered. however, to date, there is no clear research evidence to support this hypothesis. therefore the aims of the proposed study are: 1. to test the hypothesis that lifestyle interventions (i.e., dietary modification and regular, long-term aerobic exercise training) will favorably alter the natural progression of ckd in a sample of patients compared to a control group who will receive the current standard care. 2. to explore possible mechanisms that could contribute to the observed changes.


Eligibility criteria:
inclusion criteria: * stages 2-4 ckd exclusion criteria: * cad * mi

Keywords: ckd
immunogenicity, reactogenicity of shingrix in sle

Conditions: Zoster; Systemic Lupus Erythematosus; Vaccine Reaction

Summary: to investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (shingrix) in patients with sle in a randomized trial.


Eligibility criteria:
inclusion criteria: * males or females ≥ 19 years of age at time of consent * ≥4 of the 1997 acr13 or the 2012 slicc/acr criteria for sle (13, 14) * clinically stable sle * corticosteroid use: ≥ 5mg/day of prednisolone equivalent * stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks * antimalarials (≤400 mg/day) * azathioprine (≤3 mg/kg/day) * mycophenolate mofetil (≤3 mg/day) * tacrolimus (≤5mg/day) * methotrexate (≤20mg/week) * cyclosphosphamide (≤1mg/bsa/month) * must understand and voluntarily sign an informed consent form including writing consent for data protection exclusion criteria: * pregnant or lactating females * acute infection with t \>38°c at the time of vaccination * previous anaphylactic response to vaccine components or to egg * history of guillain-barre syndrome or demyelinating syndromes * any condition including laboratory abnormality which places the subject at unacceptable risk * subjects who decline to participate
entral feeding in acute severe pancreatitis

Conditions: Postoperative Nausea

Summary: • a total of 60 patients admitted to king abdulaziz specialists hospital between june 2018 and april 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: abdominal pain \> 6 on the visual analogue scale without given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at least 3 times the upper limit of the reference range (considering normal lipase level from 0-160 u/l, and normal amylase level from 0-100 u/l) with confirmed abdominal computerized axial tomography of grade d and e on ranson and colleagues criteria(28) of inflamed pancreatic picture.

* the study was conducted on monitoring of four pillar for 13 days (data collected one day before feeding and every three days for 12 days). the first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis and this monitored clinically and laboratory by fixed parameters, clinically, by abdominal pain which assessed by visual analogue scale (vas). and laboratory, by both markers of severity of pancreatic acini destruction which assessed by serum amylase, lipase and markers of severity of interstitial pancreatic tissue destruction which assessed by the level of lactate dehydrogenase level (ldh), aspartate aminotransferase (ast), c-reactive protein, prostacyclin and interleukin 8. the second pillar include effect of the two enteral feeding methods on the patient's tolerance and these monitored in our study by both post-feeding vomiting and post feeding attacks of osmotic diarrhea and also abdominal pain. third pillar include effect of the two enteral feeding methods on the patient's general condition and these monitored by follows the apache ii score, hemodynamics of the patients in both groups (mean arterial blood pressure and pulse) and arterial oxygen saturation (spo2). fourth pillar include effect of the two enteral feeding methods on achieving satisfactory nutrition parameters of the patients and both albumin level, radium blood sugar and electrolytes (sodium and potassium level) used as indicator for this. * all parameters observed one day before starting feeding and every 3 days for 12 days (duration of the study).

Eligibility criteria:
inclusion criteria: * acute pancreatitis exclusion criteria: * systemic disease as hypertension or diabetes
comparison of a blood clotting drug (recombinant factor xiii) produced by two different manufacturers in healthy male subjects

Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency; Healthy

Summary: this trial is conducted in europe. the aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant factor xiii)) produced by two different manufacturers (novo nordisk and avecia) in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.5 and 30 kg/m2 * good general health based on assessment of medical history, physical examination, ecg (electrocardiogram), and clinical laboratory data at screening, as judged by the physician * non-smokers exclusion criteria: * known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician * blood transfusion within 3 months of trial start * positive for hepatitis b or c infection * positive for human immunodeficiency virus (hiv) infection * excessive consumption of a diet deviating from a normal diet as judged by the physician * blood or plasma donation within the last 3 months prior to trial start * subjects with any history of migraine
evaluation of next-generation sequencing-based metabarcoding versus culturing for microbiological assessment in infectious keratitis

Conditions: Keratitis

Summary: infectious keratitis is a potential sight threatening condition. in conventional clinical practice culturing is performed in order to identify the causative microbial organism; however in recent years next generation sequencing for the presence of ribosomal dna from bacteria, fungi, or amoeba has become available. the present study aims to compare conventional culturing with next generation sequencing for identifying microorganism causing keratitis.

patients admitted with microbial keratitis to the department of ophthalmology at aarhus university hospital is evaluated with both conventional culturing at agar plates, broth culture, and next generation sequencing for ribosomal dna. only patients with a corneal infiltrate of a minimum of 2 mm or of 1 mm within the central 6 mm of the cornea will be included in the study. sampling includes two samples from the contralateral healthy eye to control for the patient's normal microbiome, evaluated with culturing in broth and with ngs. from the infiltrate, samples include culturing on sabouraud agar, chocolate agar, and blood agar, culturing in broth medium, and samples for ngs. a total of 100 patients will be included.

Eligibility criteria:
inclusion criteria: - patients with a corneal infiltrate of minimum 2 mm in diameter or of 1 mm diameter within the central 6 mm of the cornea exclusion criteria: - patients below 18 years of age
the effect of time-restricted eating in cardiometabolic health

Conditions: Obesity; PreDiabetes

Summary: time-restricted eating (tre) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. in rodents, tre improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. however, an understanding of the effect of tre on cardiometabolic health in people is not clear and few studies have evaluated this issue. accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h tre for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (cvd): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. the proposed studies will elucidate the cardiometabolic implications of tre in people with obesity and prediabetes.


Eligibility criteria:
inclusion criteria: * must be able to grant voluntary informed consent and comply with the study instructions * aged 25-75 years * men and women * body mass index 27-45 kg/m2 * fasting plasma glucose 5.6-6.9 mmol/l, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/l or haemoglobin a1c 39-46 mmol/mol or homeostasis model assessment-insulin resistance (homa-ir) score ≥2.73 * self-reported habitual eating period ≥ 13 h per day exclusion criteria: * shift worker * fasting \>12 h/day more than once a week * vegan * \> once a week no food intake after \~1800 h * habitually waking up before \~0400 h and sleeping before \~2100 h * unstable weight (\>5% change the last 2 months) * clinical diagnosis of type 1 or 2 diabetes * clinical diagnosis of sleep disorder * clinical diagnosis of eating disorder * clinical diagnosis of cancer in last 5 years * conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study) * use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha- or beta-adrenergic blockers or agonists, etc.) * smoking and illegal drug use * pregnant or lactating * gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy) * individuals with electromedical devises * prisoners * alcohol abuse
for health: a family-oriented healthy eating, activity and lifestyle intervention for overweight preschool children

Conditions: Childhood Obesity

Summary: in this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim of phase 2 of the project is to investigate whether a community-based, 12-month intervention for overweight and obese preschool children 2-6 years of age and their families will be effective in reducing the participants' degree of overweight (bmi z-score) and in improving quality of life. in the final phase (phase 3), participating children will be randomized to either receiving a multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6 months later (control or wait list arm), in order to generate more robust effectiveness data. participants will receive an additional free 6-month ymca membership while participating in the study.


Eligibility criteria:
inclusion criteria: * children aged 2-6 on study entry with primary overweight or obesity, bmi =\> 85th percentile for age and sex on 2010 who growth charts for canada * family meets readiness for change criteria, contemplation or higher stage, according to prochaskas transtheoretical model. * at least one parent/caregiver committed to attend all the program sessions with the child * parent/caregiver is agreeing to complete the study questionnaires at the required time points exclusion criteria: * chronic medical conditions potentially impacting program participation or associated with a potentially increased risk in participation (e.g. type 1 diabetes mellitus, heart-, gastrointestinal-, or kidney diseases, uncontrolled asthma, other physical, developmental or psychological disabilities that could limit extent of study participation * regular use of medications that could limit extent of study participation * other concurrent or recently (last 12 months)received obesity treatment * inability to read, speak, and/or verbally understand english * living outside of the greater london, ontario, area

Keywords: childhood obesity multidisciplinary preschool children community-based lifestyle intervention family-centered
registry platform gastric/esophageal cancer (saphir)

Conditions: Esophageal Squamous Cell Carcinoma; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma

Summary: the registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic esophageal, gastric or gastroesophageal junction cancer, treated in palliative intention in daily routine practice in germany.

saphir is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic esophageal, gastric or gastroesophageal junction cancer in germany. the registry will follow patients for up to two years. it will identify common therapeutic sequences and changes in the treatment of the disease. at inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. during the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. health-related quality of life (hrqol) will be evaluated for up to two years.

Eligibility criteria:
inclusion criteria: * histologically proven stage iv (metastatic) escc, eac, gac or gejac * planned palliative systemic first-line therapy * age \>= 18 years * signed informed consent (ic) * patients answering questionnaires: ic before first therapy cycle * patients not answering questionnaires: ic latest 4 weeks after start of first therapy cycle exclusion criteria: * no systemic therapy for escc, eac, gac or gejac

Keywords: neoplasms registry health services research epidemiology germany palliative treatment palliative care
burr hole ultrasound study

Conditions: Chronic Subdural Hematoma

Summary: chronic subdural hematoma (csdh) is commonly managed through burr hole evacuation. this study evaluates the feasibility of trans burr hole sonography as an alternative postoperative imaging modality. a pilot study on 20 patients who underwent burr hole surgery for csdh was therefore planned. postoperative imaging included both ct and sonographic examinations through the burr hole. we assessed the ability to measure residual subdural fluid thickness sonographically compared to ct.


Eligibility criteria:
inclusion criteria: * burr hole surgery due to chronic subdural hematoma * routine performance of an computed tomography scan within 3-7 days postoperative * ability to give informed consent exclusion criteria: * performance of prior craniotomy * performance of prior revision surgery

Keywords: burr hole ultrasound trans-burr hole tbus sonography chronic subdural hematoma